Enrollment in the Phase 2a JOURNEY trial completed -

2a期JOURNEY试验的入组工作已完成 -

exceeded planned target; topline 15-month data expected in late 2027

超出计划目标；预计于2027年下半年公布15个月的顶层数据

Veteran biotechnology executive with deep experience in complement-targeted therapies for geographic atrophy joins Board as independent Director

资深生物技术高管，在针对地图样萎缩的补体靶向疗法方面拥有深厚经验，以独立董事身份加入董事会

SOUTH SAN FRANCISCO, Calif.

加利福尼亚州南旧金山

,

，

Oct. 9, 2026

2026年10月9日

/PRNewswire/ -- Perceive Biotherapeutics, Inc. ('Perceive Bio' or the 'Company'), a biotechnology company advancing novel gene therapies in ophthalmology and adjacent indications, today announced the completion of enrollment in the Phase 2a JOURNEY study (PBI-AMD-002 the 'Study'), its Phase 1/2a clinical study of VOY-101 in patients with geographic atrophy (GA), the advanced form of non-neovascular (dry) age-related macular degeneration (AMD).

/美通社/ -- Perceive Biotherapeutics, Inc.（“Perceive Bio”或“公司”）是一家致力于推进眼科及相关适应症创新基因疗法的生物技术公司，今日宣布其2a期JOURNEY研究（PBI-AMD-002，简称“本研究”）已完成受试者入组。该研究为VOY-101在地理萎缩（GA）患者中的1/2a期临床研究，地理萎缩是非新生血管性（干性）年龄相关性黄斑变性（AMD）的晚期形式。

Enrollment exceeded the Company's planned target, and topline data from the study's 15-month primary endpoint are expected in late 2027. The Company also announced the appointment of industry veteran, Tony Gibney, to its Board of Directors as an independent Director..

入组人数超过了公司的计划目标，该研究15个月主要终点的顶层数据预计将于2027年下半年公布。公司还宣布任命行业资深人士托尼·吉布尼（Tony Gibney）为董事会独立董事。

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Perceive Bio is advancing novel gene therapy treatments in ophthalmology and related verticals.

Perceive Bio 正在推进眼科及相关领域的新型基因疗法。

Phase 2a enrollment complete, exceeding planned target

2a期入组完成，超出计划目标

JOURNEY exceeded the planned enrollment of 62 eyes to enroll 94 eyes, (47 participants). The Study is a randomized, open-label, multi-center evaluation of a single intravitreal injection of VOY-101 at the recommended Phase 2 dose established in Phase 1. Participants have bilateral GA lesions that are well-matched in size and one eye, selected by randomization, was treated with VOY-101 while the untreated fellow eye serves as the within-patient control thereby controlling for genetics, environmental exposures and participant age - all leading factors known to impact the disease course of AMD.

JOURNEY 研究的实际入组眼数为 94 只（47 名参与者），超过了计划的 62 只眼。本研究是一项随机、开放标签、多中心研究，旨在评估在 I 期研究中确定的推荐 II 期剂量下，单次玻璃体内注射 VOY-101 的疗效与安全性。参与者双眼均患有地理萎缩（GA）病灶，且病灶大小良好匹配；通过随机化选择其中一只眼接受 VOY-101 治疗，另一只未治疗的对侧眼作为患者自身对照，从而控制遗传因素、环境暴露和参与者年龄等已知影响年龄相关性黄斑变性（AMD）病程的主要混杂因素。

The primary endpoint is the change in GA lesion size at Month 15. Secondary endpoints include change in GA lesion size through Month 24, visual acuity and function measures, development of macular neovascularization, and safety and tolerability..

主要终点为第15个月时地理萎缩（GA）病灶面积的变化。次要终点包括至第24个月时地理萎缩（GA）病灶面积的变化、视力和功能指标、黄斑新生血管的发生情况，以及安全性和耐受性。

'Completing enrollment in JOURNEY, and exceeding our target, reflects the urgency felt by patients living with geographic atrophy and the strong engagement of our investigators and study sites,' said K. Angela Macfarlane, CEO of Perceive Bio. 'VOY-101 is designed as a one-time treatment that restores the body's own protective regulation of the complement pathway in patients at elevated risk of progression.

Perceive Bio首席执行官K. Angela Macfarlane表示：“JOURNEY研究的入组工作已完成，且超出我们的目标，这反映了地理性萎缩患者所感受到的迫切需求，以及我们的研究者和研究中心的高度参与。VOY-101旨在作为一种一次性治疗手段，恢复进展风险升高患者体内对补体通路的自身保护性调节。”

Approved therapies for GA require ongoing intravitreal injections, and outside the United States patients still have no approved treatment option. We believe a durable, genetically targeted gene therapy has the potential to transform how this disease is managed, and we look forward to reporting topline 15-month results in late 2027.'.

目前获批的地理萎缩（GA）疗法需要持续进行玻璃体内注射，而在美国以外，患者仍然没有获批的治疗选择。我们相信，一种持久、靶向基因的基因疗法有望改变该疾病的管理方式，并期待在2027年下半年公布15个月的顶层结果。

AMD is a leading cause of irreversible vision loss in people over 60. GA, the advanced stage of the non-neovascular (dry) form of the disease, is estimated to affect more than 1.5 million people in the United States today¹ and results in progressive loss of the retinal pigment epithelium, photoreceptors and, ultimately, of central vision..

年龄相关性黄斑变性（AMD）是60岁以上人群不可逆视力丧失的主要原因。地理萎缩（GA）是该病非新生血管性（干性）形式的晚期阶段，据估计目前在美国影响超过150万人¹，并导致视网膜色素上皮、光感受器进行性丧失，最终导致中心视力丧失。

Industry veteran Tony Gibney joins the Company's Board of Directors

行业资深人士托尼·吉布尼加入公司董事会

Perceive Bio is also pleased to announce that Tony Gibney has joined the Company's Board of Directors as an independent Director. Mr. Gibney is an experienced biotechnology executive and former investment banker with more than 30 years of experience leading and advising companies across finance, business development and strategy.

Perceive Bio 很高兴地宣布，Tony Gibney 已加入公司董事会，担任独立董事。Gibney 先生是一位经验丰富的生物技术行业高管和前投资银行家，在金融、业务发展和战略领域拥有超过 30 年的领导和咨询经验。

Most recently, he served as Chief Financial and Business Officer of Aura Biosciences, Inc., a late-stage company focused on rare ocular oncology indications. Previously, he was Executive Vice President, Chief Business & Strategy Officer of Iveric Bio, Inc. until its acquisition by Astellas Pharma Inc.

最近，他担任Aura Biosciences, Inc.（一家专注于罕见眼科肿瘤适应症的后期阶段公司）的首席财务与业务官。此前，他在Iveric Bio, Inc.被安斯泰来制药株式会社收购之前，曾担任该公司的执行副总裁兼首席业务与战略官。

in 2023; Iveric was one of the first companies to receive approval for a complement inhibitor for geographic atrophy in the U.S. and other markets. Prior to that, Mr. Gibney served as Chief Financial Officer and Chief Business Officer of Fog Pharmaceuticals, Inc. (now Parabilis Medicines) and as Executive Vice President and Chief Business Officer of Achillion Pharmaceuticals, Inc., where he led the company's sale to Alexion Pharmaceuticals, Inc.

2023年，Iveric成为首批在美国及其他市场获得地理性萎缩症补体抑制剂批准的公司之一。在此之前，吉布尼先生曾担任Fog Pharmaceuticals, Inc.（现为Parabilis Medicines）的首席财务官兼首席商务官，以及Achillion Pharmaceuticals, Inc.的执行副总裁兼首席商务官，在那里他领导了该公司向Alexion Pharmaceuticals, Inc.的出售。

in 2020. Earlier in his career, he was Managing Director and Co-head of Biotechnology Investment Banking at Leerink Partners LLC and a Managing Director in Merrill Lynch's Healthcare Investment Banking Group. He currently serves on the Boards of Directors of LAPIX Therapeutics, Inc. and InflaRx N.V..

2020年。在职业生涯早期，他曾担任Leerink Partners LLC的执行董事兼生物技术投资银行联席主管，以及美银美林医疗保健投资银行集团的执行董事。他目前担任LAPIX Therapeutics, Inc.和InflaRx N.V.的董事会成员。

'Tony brings a rare combination of financial, strategic and operating experience to the Perceive Bio Board, including a direct role in bringing one of the first complement inhibitors for geographic atrophy to market,' said Cameron Wheeler, Partner at Deerfield Management. 'His perspective on the GA landscape and on building companies through late-stage development and strategic transactions will be invaluable as Perceive Bio approaches its Phase 2a readout and plans the next stage of VOY-101's development.'.

“托尼为 Perceive Bio 董事会带来了罕见的金融、战略和运营经验组合，其中包括在推动首批用于治疗地图样萎缩的补体抑制剂之一上市过程中发挥的直接作用。”Deerfield Management 合伙人卡梅伦·惠勒表示。“随着 Perceive Bio 即将公布其二期a临床试验结果，并规划 VOY-101 开发的下一阶段，他对地图样萎缩领域格局以及通过后期开发和战略交易构建公司的见解将具有不可估量的价值。”

'I am delighted to join the Perceive Bio Board at such an important time for the Company,' said Mr. Gibney. 'Having spent a significant part of my career in ophthalmology and in complement biology, I have seen firsthand the need among patients with geographic atrophy for more effective and durable treatments.

“在公司如此重要的时刻加入 Perceive Bio 董事会，我深感荣幸，”吉布尼先生表示。“在我的职业生涯中，我有相当一部分时间致力于眼科和补体生物学领域，因此我亲眼目睹了地理性萎缩患者对更有效、更持久治疗方案的迫切需求。

Perceive's genetic-driven science and one-time, intravitreal injection gene therapy design have the potential to address that need by targeting CFH directly and thereby disrupting the natural progression of GA at its source.'.

Perceive 基于遗传学的科学方法及其一次性玻璃体内注射基因疗法设计，有望通过直接靶向 CFH 并从源头上干扰地理性萎缩（GA）的自然进展，来满足这一需求。

About VOY-101 and the JOURNEY Study

关于 VOY-101 和 JOURNEY 研究

VOY-101 is an investigational recombinant adeno-associated virus gene therapy encoding a form of the protective variant of Complement Factor H. Delivered by a single intravitreal injection, VOY-101 is designed to produce ongoing therapeutic protein to restore regulation of the complement pathway and slow the progression of GA, with the potential to serve as a one-time therapy..

VOY-101 是一种研究性重组腺相关病毒基因疗法，编码补体因子 H 的保护性变异体形式。通过单次玻璃体腔注射给药，VOY-101 旨在持续产生治疗性蛋白，以恢复补体通路的调控并减缓地理性萎缩（GA）的进展，有望成为一次性疗法。

The JOURNEY study (PBI-AMD-002; ClinicalTrials.gov identifier NCT06087458) is a prospective, randomized, fellow-eye controlled, multi-center study of a single intravitreal injection of VOY-101 in patients with GA secondary to AMD. Study evaluates the efficacy and safety of VOY-101 in the treated study eye compared with the untreated, well-matched fellow eye in patients with bilateral GA.

JOURNEY 研究（PBI-AMD-002；ClinicalTrials.gov 标识符 NCT06087458）是一项前瞻性、随机、对侧眼对照、多中心研究，旨在评估单次玻璃体腔注射 VOY-101 在治疗继发于年龄相关性黄斑变性（AMD）的地理萎缩（GA）患者中的效果。该研究比较了双眼均患有 GA 的患者中，接受治疗的 study eye 与未治疗且匹配良好的对侧眼之间 VOY-101 的疗效和安全性。

Participants are followed for 24 months..

参与者将被随访24个月。

About Perceive Biotherapeutics, Inc.

关于 Perceive Biotherapeutics, Inc.

Perceive Biotherapeutics is advancing novel gene therapy treatments in ophthalmology and related verticals. Perceive was founded on compelling research elucidating novel protective biology for treating retinal blindness, including dry AMD, developed from foundational collaborations in genetic science and target validation.

Perceive Biotherapeutics 正在推进眼科及相关领域的新型基因疗法。Perceive 的成立基于极具潜力的研究成果，这些成果阐明了用于治疗视网膜失明（包括干性年龄相关性黄斑变性）的新型保护性生物学机制，其研发源于在遗传科学和靶点验证方面的基础性合作。

The Company is backed by Deerfield Management, Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc., GV, Braidwell LP, Gund Vision Fund (formerly known as Retinal Degeneration Fund), and Catalio Capital Management, LP. For more information, please visit .

本公司获得以下机构的支持：Deerfield Management、强生公司（通过其企业风险投资机构 Johnson & Johnson Innovation – JJDC, Inc.）、GV、Braidwell LP、Gund Vision Fund（前身为 Retinal Degeneration Fund）以及 Catalio Capital Management, LP。如需更多信息，请访问 。

www.perceivebio.com

www.perceivebio.com

.

。

¹ Friedman DS, O'Colmain BJ, Muñoz B, et al.; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122(4):564–572. Friedman et al. estimated approximately 973,000 Americans with GA in 2000; the current figure applies that prevalence to the growth in the U.S.

¹ Friedman DS, O'Colmain BJ, Muñoz B 等；眼病患病率研究组。美国年龄相关性黄斑变性的患病率。《眼科档案》. 2004;122(4):564–572。Friedman 等人估计，2000 年美国约有 973,000 名地理性萎缩（GA）患者；当前数据是将该患病率应用于美国人口增长后得出的。

population aged 65 and older, from 35.0 million in the 2000 Census to 61.2 million in 2024 (U.S. Census Bureau, Vintage 2024 Population Estimates)..

65岁及以上人口从2000年人口普查的3,500万增加到2024年的6,120万（美国人口普查局，2024年年度人口估计）。

Media Contact

媒体联系人

For Perceive Bio:

致Perceive Bio：

Anne Rubin, President (

安妮·鲁宾，总裁（

[email protected]

[email protected]

)

）

SOURCE Perceive Biotherapeutics, Inc.

来源：Perceive Biotherapeutics, Inc.

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